BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6301577 · Received February 3, 2017

    Report

    Report Number
    3007566237-2017-00566
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 1, 2017
    Report Date
    February 14, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. CORRECTION: THE DEVICE INFORMATION WAS PREVIOUSLY REPORTED AS AN IMPLANTED INS, HOWEVER AT THE TIME OF THE SYMPTOMS THE PATIENT HAD A TRIAL DEVICE.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED. A HEALTHCARE PROVIDER (HCP) REPORTED THE PATIENT'S PREVIOUSLY REPORTED TIA WAS NOT RELATED TO THE DEVICE OR THERAPY. NO ACTIONS WERE REQUIRED TO RESOLVE THE TIA SYMPTOMS AND THOSE SYMPTOMS HAD BEEN RESOLVED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED VIA THE MANUFACTURER¿S REPRESENTATIVE (REP) THE CONSUMER PREVIOUSLY HAD A DIFFERENT MANUFACTURER¿S SYSTEM IMPLANTED AND HAD A TIA. ON (B)(6) 2017 THE CONSUMER STARTED A TRIAL WITH PADDLE LEADS IN C AND T AND THEN HAD THE BATTERIES IMPLANTED ON (B)(6) 2017. SOMETIME DURING THE TRIAL THE CONSUMER BEGAN TO HAVE TIA SYMPTOMS AGAIN WHICH HAD IMPROVED, BUT THEY WANTED PERFORM AN MRI TO VERIFY, BUT IT WAS UNKNOWN IF THIS WAS RELATED TO THE DEVICE OR THERAPY SINCE THE HCP THOUGHT IT COULD BE RELATED TO THE NEW IMPLANT OR THE PREVIOUSLY IMPLANTED SYSTEM. RELEVANT MEDICAL HISTORY INCLUDES SPINAL PAIN. REFER TO MANUFACTURING REPORT #3007566237-2017-00565.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85206 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other